FDA Medical Device Recalls (openFDA)
Linvatec Corp.: Ultra Power Burs, Sterile, Single-Use.
- Recall number
- Z-0041-05
- Recalling firm
- Linvatec Corp.
- Product
- Ultra Power Burs, Sterile, Single-Use.
- Status
- Terminated
- Initiated
- 2004-08-26
- Posted
- 2004-10-23
- Terminated
- 2012-07-06
- Reason
- The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.
- Root cause
- Packaging process control
- Action
- Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product.
- Quantity
- 58510 units
- Distribution
- Distributed to 492 customers throughout the United States, and 301 customers internationally.
- Lot, serial or model codes
- All product with an expiration date between August 2004 and August 2009.
- 510(k) numbers
- ["K781979","K981636"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1017294
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28